National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)

Purpose

This
Request for Information (RFI) is directed toward determining the types of
technologies that could be used for the development of a point of care (POC)
device for the diagnosis of Sickle Cell Disease in newborns and young children
in low-income and low-resources settings. This information will be used to
assess the current state of the field and identify potential
companies/universities with the interest and expertise to engage in this
research.

Background

The
World Health Organization (WHO) has declared Sickle Cell Disease (SCD) a public
health priority. The greatest burden of SCD is in sub-Saharan Africa, where 75%
of the 300,000 annual global births of affected children live. Estimates
suggest that 50-80% of these children will die by 5 years of age. While treatment
options are currently available, in order for affected populations to benefit
from these therapies it is important to be able to identify those who require
treatment and to administer appropriate therapies in a timely way. In rural
parts of Africa, particularly Sub-Saharan Africa, a SCD diagnosis is rarely
made before the age of 2-3 years, and many undiagnosed children die in early
infancy due to potentially treatable illnesses such as meningitis, pneumonia or
acute anemia. Traditional neonatal screening for SCD is not an effective
diagnostic intervention in this setting. A more pragmatic use of limited health
care fiscal resources in low-income countries would involve the widespread
integration of highly sensitive and specific POC testing into the infant’s
/child’s first acute care visit at a local medical facility. The implementation
of a low-cost and accurate POC diagnostic device would allow earlier SCD
testing, diagnosis, and acute and long term treatment of children, thereby reducing
the risk of future SCD-related complications.

Information
Requested

NHLBI
requests responses to all or some of the following items:

Identify the
scientific technologies such as molecular, biochemical, genomic, microfluidic,
HPLC, etc. that have the potential for POC application in low-resource settings.
Device characteristics in such a setting would include: cost efficiency, rapid
response, specificity, low maintenance, reliability, portability, ease of
operation, and energy efficiency. The device must be capable of differentiating
homozygotes (SS) from heterozygotes (AS). Comment as to whether the device
could be adapted to detect other major hemoglobinopathies such as Thalassemia.
Include a statement whether a new device may be required or if existing medical
devices could be adapted.

Since the
intended POC user will not typically have laboratory training, and the
patient-side blood testing environment is not as controlled as the standard
laboratory environment, describe how the POC product design could achieve the
laboratory’s standard of analytical performance (e.g., robustness).

Identify
obstacles to developing POC devices in low-resource settings and provide
recommendations for overcoming them. Recommendations may include specific
funding mechanisms or programs that would enhance the development of POC
device.

Identify
any ethical issues related to device development in children, particularly in
non-emergency settings, that should be addressed when planning a device
development program.

Provide
input on current pediatric device regulatory requirements.

Confidentiality

Responses
to this RFI are voluntary. Any personal identifiers (e.g., names, addresses,
email addresses, etc.) will be removed when responses are compiled. Only the
de-identified comments will be used. Proprietary, classified, confidential, or
sensitive information should not be included in your response. The United
States government reserves the right to use any non-proprietary technical
information in any resultant solicitation(s).

This
RFI is for information and planning purposes only and should not be construed
as a solicitation or as an obligation on the part of the United States government
to provide support for any ideas identified in response to it. Please note that
the United States government will not pay for the preparation of any
information submitted or for its use of that information. Responses will be
compiled and shared internally and with the National Heart, Lung, and Blood
Advisory Council, with one or more subcommittees of the Council, and with
scientific working groups convened by the NHLBI, as appropriate. In all cases where
responses are shared, the names of the respondents will be withheld.

How to Submit
a Response

Interested
extramural investigators and other interested parties are invited to
respond.

Responses
to this RFI will be accepted through May 4, 2012. You will not receive
individualized feedback on any suggestions. No basis for claims against the United
States government shall arise as a result of a response to this request for
information or from the United States government's use of such information.

All
comments must be submitted via email (include NOT-HL-12-140 in the subject
line) to the following: